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Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis

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ClinicalTrials.gov Identifier: NCT01001559
Recruitment Status : Completed
First Posted : October 26, 2009
Results First Posted : December 19, 2013
Last Update Posted : December 19, 2013
Sponsor:
Collaborators:
Red Oak Psychiatry Associates, PA
Baylor Health Care System
Information provided by (Responsible Party):
Pamlab, Inc.

Tracking Information
First Submitted Date October 22, 2009
First Posted Date October 26, 2009
Results First Submitted Date April 19, 2013
Results First Posted Date December 19, 2013
Last Update Posted Date December 19, 2013
Study Start Date August 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 25, 2013)
Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline [ Time Frame: 60 days ]
The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient's illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms. Number of patients with an improvement in CGI-S scores as demonstrated by a reduction in ≥2 points (major improvement) from baseline.
Original Primary Outcome Measures
 (submitted: October 23, 2009)
Improvement as measured by Clinical Global Impression of Improvement (CGI-I) [ Time Frame: Every 2 weeks for 8 weeks ]
Change History Complete list of historical versions of study NCT01001559 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 25, 2013)
  • Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale [ Time Frame: 60 days ]
    The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient's illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms. Median times to peak response. Peak response defined as the first improvement of two or more in the CGI-S from initial visit, and measured the time to the occurrence.
  • Number of Hospitalizations Due to MDD [ Time Frame: 60 days ]
    Number of hospitalizations due to MDD during treatment were assessed during this retrospective analysis of L-methylfolate plus SSRI/SNRI at treatment initiation (n=95) and SSRI/SNRI monotherapy (n-147) from patient charts
  • Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications [ Time Frame: 60 days ]
Original Secondary Outcome Measures
 (submitted: October 23, 2009)
  • Change in Clinical Global Impression of Severity (CGI-S) score [ Time Frame: Every 2 weeks for 8 weeks ]
  • Length of time to peak response [ Time Frame: Every 2 weeks for 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis
Official Title Combination Deplin® and Antidepressant Therapy Compared to Antidepressant Therapy Alone for an Episode of Major Depression- a Retrospective Analysis
Brief Summary This is a retrospective chart review study to determine if Deplin® 7.5mg-15mg combined with an antidepressant is better than an antidepressant alone in adults with major depression.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adults ages 18-70 experiencing an episode of major depression
Condition Major Depressive Disorder
Intervention
  • Drug: L-methylfolate
    Subjects must have been on their respective therapies for a minimum of 60 days. L-methylfolate dosing was 7.5 mg or 15 mg daily
    Other Name: Deplin
  • Drug: Selective serotonin reuptake inhibitor (SSRI)
    Subject must have been on their respective therapy for a minimum of 60 days. Because this was an observational retrospective analysis, dosing of SSRI/SNRI varied on a per patient basis.
  • Drug: Serotonin and norepinephrine reuptake inhibitor (SNRI)
    Subject must have been on their respective therapy for a minimum of 60 days. Because this was an observational retrospective analysis, dosing of SSRI/SNRI varied on a per patient basis.
Study Groups/Cohorts
  • Deplin + antidepressant
    Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
    Interventions:
    • Drug: L-methylfolate
    • Drug: Selective serotonin reuptake inhibitor (SSRI)
    • Drug: Serotonin and norepinephrine reuptake inhibitor (SNRI)
  • Antidepressant alone
    SSRI or SNRI alone
    Interventions:
    • Drug: Selective serotonin reuptake inhibitor (SSRI)
    • Drug: Serotonin and norepinephrine reuptake inhibitor (SNRI)
Publications * Ginsberg LD, Oubre AY, Daoud YA. L-methylfolate Plus SSRI or SNRI from Treatment Initiation Compared to SSRI or SNRI Monotherapy in a Major Depressive Episode. Innov Clin Neurosci. 2011 Jan;8(1):19-28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 9, 2012)
242
Original Estimated Enrollment
 (submitted: October 23, 2009)
250
Actual Study Completion Date June 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Males or females age 18-70
  • The active arm (Arm #1) includes randomly selected 100-125 charts of patients with a primary diagnosis of major depression and a CGI-S of ≥4 who began Deplin and SSRI or SNRI therapy at the same time beginning in January 2007 to the present; and, Control group (Arm #2) includes randomly selected 125-150 charts of patients with a primary diagnosis of major depression who began SSRI or SNRI therapy matched in severity (CGI-S of ≥4)

Exclusion Criteria:

  • Folic acid >400 mcg taken at any time during the study
  • Psychotic features in the current episode or a history of psychotic features
  • Any bipolar disorder (current or past) or any psychotic disorder (current or past)
  • Current or past treatment with vagus nerve stimulation, ECT, or transcranial magnetic stimulation
  • Antipsychotic therapy in conjunction with their antidepressant currently or in past 4 weeks
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01001559
Other Study ID Numbers Pamlab D-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pamlab, Inc.
Study Sponsor Pamlab, Inc.
Collaborators
  • Red Oak Psychiatry Associates, PA
  • Baylor Health Care System
Investigators
Principal Investigator: Lawrence D Ginsberg, MD Red Oak Psychiatry Associates, PA
PRS Account Pamlab, Inc.
Verification Date November 2013